- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03170700
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
Use of Engaging Online Videos in Conjunction With New Feeding Content to Enhance a Current EFNEP Program in the Prevention of Child Obesity
Descripción general del estudio
Estado
Condiciones
Descripción detallada
During Phase I of the project (first two years), the leadership team composed of both research and extension investigators will work with the media production team to edit the SEEDS videotapes to meet the needs of the current project and to develop the website and activities for use in the online condition. Phase II (second three years) will be a large scale evaluation of this program. In this phase, classes of EFNEP participants in Colorado and Washington will be randomly assigned to one of three conditions: 1) Eating Smart • Being Active alone (control); 2) Eating Smart • Being Active plus feeding videos at the weekly EFNEP sessions, plus facilitated group discussion (in-person); or 3) Eating Smart • Being Active plus online videos and activities, (online). Pre- and post-program assessments, 6- and 12-month follow ups will be conducted to assess responsive feeding, providing structure, food exploration, child eating behaviors, parent knowledge, and child dietary intake. Child dietary intake will be obtained on a sub-sample of 90 participants. In Phase III, the investigators will begin dissemination.
A total of 543 participants were recruited in five locations to participate in the project: 262 from three counties in Colorado and 281 from three counties in Washington (English and Spanish participants). A total of 4 to 10 mothers were recruited for each group. After recruitment, groups were randomly assigned to the three conditions ensuring a relatively equal number of participants per condition.
Data from children who have any kind of food allergies or diabetes or are on special diet will be excluded from the analyses.
To ensure program fidelity, program educators will complete implementation checklists, and 20% of the sessions will be attended by an additional grant staff member to conduct implementation observations and assess participant engagement. Detailed records of participant attendance will be collected to assess dosage effects and attrition. All assessments will be conducted by grant project staff blind to the group status of the participants. Retention of participants will be maximized using strategies such as obtaining multiple phone numbers for each family; obtaining external contact information for siblings and close friends; sending interim reminders with the goal of fostering contact should the family move; and phone calls, emails or letters between data collection points to each family.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Colorado
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Fort Collins, Colorado, Estados Unidos, 80523
- Colorado State University
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Washington
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Pullman, Washington, Estados Unidos, 99164
- Washington State University
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Parents who attend EFNEP programs in the states of WA and CO.
Exclusion Criteria:
- Parents with children younger than age 2 and older than age 8 will be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
Participants will receive a nutrition program without parental feeding content.
They will attend the nutrition program (Eating Smart • Being Active).
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|
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Experimental: In-person
Nutrition program with in-person parental feeding content.
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Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
|
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Experimental: Online
Nutrition program with online parental feeding content.
|
Participants will attend the nutrition program (Eating Smart • Being Active).
They will access parental feeding content online.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Responsive Feeding from the modified Child Feeding Questionnaire
Periodo de tiempo: Up to 12-month follow up
|
Five subscales measuring responsiveness, restriction, use of food as reward, monitoring, and pressure to eat will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
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Up to 12-month follow up
|
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Providing Structure from the modified Child Feeding Questionnaire
Periodo de tiempo: Up to 12-month follow up
|
Seven subscales measuring parent decides on portions, family meals, serves measured portions, child helps prepare, eat whenever, indulgent feeding, and eat at regular times will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
|
Novel Foods from the modified Child Feeding Questionnaire
Periodo de tiempo: Up to 12-month follow up
|
Four subscales measuring encouraging exploration, offering new foods, urging new foods, and low pressure strategies for encouragement will be assessed using a 5-point Likert scale.
Parents will report on these constructs that assess responsive feeding.
|
Up to 12-month follow up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parental Knowledge Questionnaire
Periodo de tiempo: Up to 12-month follow up
|
A questionnaire measuring aspects of feeding and nutrition knowledge and content covered in the prevention curriculum will be assessed.
|
Up to 12-month follow up
|
|
Child Eating Behaviors
Periodo de tiempo: Up to 12-month follow up
|
Parental report of child eating behaviors
|
Up to 12-month follow up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sheryl O Hughes, PhD, Baylor College of Medicine
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-36455
- 2015-68001-23311 (Otro identificador: USDA)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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